Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT07230834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1 Dose-Escalation and Repeated-Dose Study of the Safety and Tolerability of Intravitreal Pozelimab in Participants With Geographic Atrophy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIENNA
Brief Summary:
This study is researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA).
The aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood and the fluid in the eye at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
The aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood and the fluid in the eye at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-521758-40-00 | CTIS | None | View |